Coronary Artery DiseaseCUT-DRESSNCT05801003
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).
A study testing Predilation with cutting balloon. and Predilation with conventional balloon in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Hospital Universitario La Fe at 3 sites in Spain.
Trial summary
Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Cutting Balloon
- What is being tested?
- Predilation with cutting balloon. and Predilation with conventional balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Feb 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses >50% in a native coronary artery.
Who cannot join
- Cardiogenic shock
- Patients presenting with ST-segment elevation myocardial infarction
- Patients undergoing chronic total occlusions PCI
- Patients undergoing left main PCI
- Patients undergoing venous bypass graft lesions PCI
- Patients with in-stent restenosis
Show all 10Show fewer
- Inability to provide informed consent
- Life expectancy <1year due to non-cardiac disease
- Currently participating in another trial before reaching first endpoint
- There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Estefania Fernandez Peregrina
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Jorge Sanz Sanchez, MD, PhD, 440087, sjorge4@gmx.com
Jose Luis Diez Gil, MD, PhD
- Not yet recruiting
Hospital General de Valencia
Valencia
Eva Rumiz González, MD, PhD
About this study
Official title: Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation
Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur.
Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions
Read the detailed description
The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease.
A total of 96 patients with de novo coronary artery stenosis will be included.
After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:
- Study group: Pre-dilation with cutting balloon followed by ASES implantation.
- Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.
Stent optimisation will be performed based on intracoronary imaging findings.
- Being tested
- Predilation with cutting balloon., Predilation with conventional balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predilation with cutting balloon.Device
Also called Wolverine Cutting balloon
PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.
Predilation with conventional balloonDevice
PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Pre-dilation with cutting balloon followed by ASES implantation. Receives: Device: Predilation with cutting balloon. |
| Control group | Active comparator | Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation. Receives: Device: Predilation with conventional balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum stent area post-stenting measured by optimal coherence tomography (OCT)
Measured: Immediately after the procedure
Secondary outcomes (14)
Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).
Key secondary
Measured: 9 month follow-up.
Mean stent area measured by optimal coherence tomography
Measured: 9 month follow-up.
Acute procedural success
Measured: Immediately after the procedure
Coronary disection
Measured: Immediately after the procedure
Malapposition (Major/minor) post-stenting measured by optimal coherence tomography
Measured: Immediately after the procedure and at 9 month follow-up
Mean neointimal hyperplasia area measured by optimal coherence tomography
Measured: 9 months
Minimum stent eccentricity measured by optimal coherence tomography
Measured: 9 months
Stent asymmetry index measured by optimal coherence tomography
Measured: 9 months
All cause death
Measured: 12 months
Death from cardiovascular causes
Measured: 12 months
Target vessel myocardial infarction
Measured: 12 months
Target lesion revascularization
Measured: 12 months
Stent thrombosis
Measured: 12 months
Any myocardial infarction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Feb 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Sanz Sanchez, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801003
- Sponsor's protocol ID
- 529
- Acronym
- CUT-DRESS
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT05801003
- Acronym / sponsor ID
- CUT-DRESS / 529
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur.
Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions
Detailed description
The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease.
A total of 96 patients with de novo coronary artery stenosis will be included.
After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:
- Study group: Pre-dilation with cutting balloon followed by ASES implantation.
- Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.
Stent optimisation will be performed based on intracoronary imaging findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Predilation with cutting balloon.Pre-dilation with cutting balloon followed by ASES implantation. |
| Control group | Active comparator | Device: Predilation with conventional balloonPre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses >50% in a native coronary artery.
Key exclusion criteria (10 listed)
- Cardiogenic shock
- Patients presenting with ST-segment elevation myocardial infarction
- Patients undergoing chronic total occlusions PCI
- Patients undergoing left main PCI
- Patients undergoing venous bypass graft lesions PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predilation with cutting balloon.Also: Wolverine Cutting balloonPCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon. | Device | Study group |
| Predilation with conventional balloonPCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant) | Device | Control group |
Primary outcome
Minimum stent area post-stenting measured by optimal coherence tomography (OCT)
Time frame: Immediately after the procedure
14 secondary outcomes
Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).
Time frame: 9 month follow-up.
Mean stent area measured by optimal coherence tomography
Time frame: 9 month follow-up.
Acute procedural success
Time frame: Immediately after the procedure
Coronary disection
Time frame: Immediately after the procedure
Malapposition (Major/minor) post-stenting measured by optimal coherence tomography
Time frame: Immediately after the procedure and at 9 month follow-up
Mean neointimal hyperplasia area measured by optimal coherence tomography
Time frame: 9 months
Minimum stent eccentricity measured by optimal coherence tomography
Time frame: 9 months
Stent asymmetry index measured by optimal coherence tomography
Time frame: 9 months
All cause death
Time frame: 12 months
Death from cardiovascular causes
Time frame: 12 months
Target vessel myocardial infarction
Time frame: 12 months
Target lesion revascularization
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
Any myocardial infarction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predilation with cutting balloon. and Predilation with conventional balloon in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Hospital Universitario La Fe at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum stent area post-stenting measured by optimal coherence tomography (OCT) (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.